DE LA SALLE HEALTH SCIENCES INSTITUTE

Dasmarinas, Cavite
Evidence Based Medicine

Saldua, Maria Michellaida Therese Sanchez, Christine Sheryl

Samala, Edward Raphael Sandoval, Rassiel Ann
Samson, Pauline Trisha Santos, Jemelda Carmen
San Miguel, Camille Anne Santos, Ma. Christina
San Pedro, Christine Marie Saqui, Vhernadette Joy

APPRAISING AN ARTICLE ABOUT THERAPY

Comparison of Negative Pressure Wound Therapy Using Vacuum-Assisted
Closure With Advanced Moist Wound Therapy in the Treatment of
Diabetic Foot Ulcers
by
PETER A. BLUME, DPM, JODI WALTERS, DPM, WYATT PAYNE, MD
JOSE AYALA, DPM & JOHN LANTIS, MD

APPRAISAL FORM FOR THERAPY

I. Evaluating Directness
1. Does the study provide a Yes.
direct enough answer to Journal Patient
your clinical question in (Research Question) (Clinical
terms of type of patients (P), Question)
exposure/intervention (E), Patient The patient population Diabetic adult Match
and outcome (O)? consisted of diabetic (73 years old)
adults 18 years with a with a Grade 4
stage 2 or 3 (as defined gangrenous
by Wagner’s scale) ulcer (as
calcaneal, dorsal, or defined by the
plantar foot ulcer 2 cm2 Wagner’s
in area after scale) on his
debridement. (First hallux before
page, first paragraph amputation
under Research Design
and Methods)

Exposure The NPWT system used The patient is Match

in this study was currently
vacuum-assisted closure treated with
therapy. The system vacuum assited
consists of three therapy.
components: a negative
pressure generating unit
with a disposable
 canister, a pad with
evacuation tube, and a
reticulated, open cell
sterile polyurethane or a
dense open-pore
polyvinyl alcohol foam
dressing cut to fit the
wound. (Second page,
second paragraph under
Research Design and
Methods)
Outcome Results of the largest Vacuum Match
NPWT RCT to date assited therapy
demonstrate that NPWT to be used as a
is as safe as and more tool for more
efficacious than AMWT efficient
in the treatment of wound healing.
DFUs. A significantly
greater number of NPWT
patients achieved
complete ulcer closure
and granulation tissue
formation than AMWT
patients. This result was
supported by a
significant reduction in
median time needed to
heal DFUs. For both
treatments, 90% of
therapy days occurred in
the home care setting.
(Fourth page, first
paragraph under
Conclusion)
II. Appraising Validity
1. Were patients randomly YES.
assigned to treatment
groups? Written on page 631, 3rd sentence under Research Design and
Methods: “Patients were randomly assigned to either NPWT
(vacuum-assisted closure) or AMWT (predominantly hydrogels and
alginates).”

Written on page 632, 2nd column, 2nd paragraph, 2nd sentence

under Research Design and Methods: “Randomization was
accomplished by generating blocks of numbers through
http://www.randomizer.org.”
2. Was allocation concealed?
3. Were baseline characteristics
similar at the start of the
trial?
4. Were patients blinded to
treatment assignment?
5. Were caregivers blinded to
treatment?
6. Were study personnel
blinded to treatment
assignment?
7. Were all patients analyzed
under the groups to which
they were originally
randomized?
8. Was follow-up rate
adequate?
YES.
Written on page 632, 2nd column, 2nd paragraph, 4th sentence
under Research Design and Methods: “Envelopes were
sequentially numbered before clinical trial site distribution.
Treatment was assigned on the basis of the next sequentially
labeled envelope.”
YES.
The inclusion and exclusion criteria for choosing the patient
population is listed under research and design methods on page
632.
NO.
Written on page 632, 2nd column, 3rd paragraph, 2nd sentence
under Research Design and Methods: “In this study, the physical
differences between treatment regimens (e.g., hydrogels and
NPWT) can be so distinctive that it is not possible to blind either
the patient or physician to the treatment after random
assignment.”
NO.
As previously stated above, there were distinct physical differences
between the two treatment regimens (NPWT and AMWT) that it
was impossible to blind both the patient and physician to the
treatment even after randomization.
NO.
As previously mentioned there was no blinding involved in this
study.
YES.
Written on page 632, 2nd column, 5th paragraph, 3rd sentence
under Research Design and Methods: “At each study visit, ulcers
were assessed for area via wound tracing, ulcer closure, and/or
adequate granulation tissue formation. NPWT dressing changes
were performed every 48-72 hours, while patients randomly
assigned to AMWT were treated on the basis of manufacturer’s
guidelines.”
YES.
 Written on page 631, 5th sentence under Research Design and
Methods: “Patients whose wounds achieved ulcer closure were
followed at 3 and 9 months.”

III. Interpreting Results

1. How large was the effect of
treatment? Complete Closure of Ulcer
Old intervention: APWT New intervention: NPWT
Treated: 28.9% Treated: 43.2%
Failure: 71.1% Failure: 56.8%

Absolute Risk Reduction

= Rc – Rt
= 0.711 – 0.568
= 0.143
0.143 > 0 = Treatment is beneficial

Relative risk
= Rt / Rc
= 0.568 / 0.711
= 0.799
0.799 < 1.0 = Treatment is beneficial

Relative risk reduction

= Rc – Rt
Rc
= (0.143 / 0.711)%
= 20.1%
20.1% > 0% = Treatment is beneficial

Absolute risk reduction, relative risk and relative risk reduction

were computed and indicated that the values were beneficial as
treatment.

It can be comprehended that the use of NPWT is 20.1% beneficial

for complete closure of ulcer using Relative Risk Reduction.
2. How precise was the The use of NPWT after an amputation from diabetic foot ulcer
estimate of the treatment increases the chances of complete ulcer closure in patients by
effect? 20.1% using RRR.

A greater proportion of foot ulcers achieved complete ulcer closure

with NPWT (73 of 169, 43.2%) than with AMWT (48 of 166, 28.9%)
within the 112-day active treatment phase (P 0.007).
IV. Assessing Applicability:
Are the results applicable
to the patients you see?
1. Are there biologic issues that There are no biologic issues that may affect applicability of
may affect applicability of treatment, considering the influence of sex, co-morbidity, race, age
treatment? (Consider the and pathology. This is evident on page 632 under Results, 2nd
influence of sex, co- paragraph. It stated, “The data suggest that no statistically
morbidity, race, age and significant demographic differences existed between treatment
pathology) arms (Table 1).”
2. Are there socio-economic There are no socio-economic issues that may have an effect on the
issues affecting applicability outcome of the treatment.
of treatment?
V. Individualizing the results: Are the benefits to your patients worth the harm and costs?
1. Are the benefits to your
patients worth the harm
a. A 73 year old male with Type 1 diabetes with post-
costs? operative amputation has a 20% risk of non-wound healing
b. if the patient above is treated with negative pressure
wound therapy, we can decrease the chance of non-wound
healing (RR: 0.799)
c. Rt = Rc x RR = 20% x 0.799 = 15.98%
d. ARR = Rc-Rt = 20% - 15.98% = 4.02%
e. NNT = 100/ARR = 100/4.02 = 25
Cost
● According to a study by Ranjeet & Dy (2012), depending on
length of time used and number of dressing change
required the total cost may be from 30,000 to 40,000
Nepalese Rupee per patients.
● Converting this to peso, the treatment’s cost is about
13,395.78 - 17,861.04 pesos.

NNT x cost = 334,894.50 to 446,526 pesos

Pros
● helps speed up the wound healing process, leading to a
shorter hospital stay
● no surgical procedure required, no anesthesia risks
● available in many medical setting
Cons
● cost
● Patients with extensive diabetic skin damage must first
undergo a procedure to cleanse wounds from dead skin
debris before initiating VAC therapy
Conclusion
The likely treatment benefits are worth the potential harm and
cost.